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本文以药品生产企业为例,探讨智慧文件管理系统的定义、需求,再结合国内外制药行业药品生产质量管理规范(GMP)检查缺陷项目现状和数据完整性的要求,以数据的4W(who,when,where,what)属性为基础,探讨智慧化文件系统的构建思路,通过3个设计的运用举例来展现该系统具备搜索和逻辑运算功能的显著特点,并预见该系统的优点和实施难点。该系统将有利于制药4.0背景下的工厂实现高效、便捷地利用各类文件进行信息检索和逻辑运算,使得药品研发和注册工作更加科学、系统、有序,同时也利于国际标准化录入和建立绿色低碳、信息化、智能化、国际化的制药核心技术平台。
This paper takes the pharmaceutical manufacturing enterprise as an example to discuss the definition and requirement of the WMS, and then examines the current status and data integrity requirements of the GMP in domestic and foreign pharmaceutical industry. Based on the data of 4W (who, when, where, what) attributes, this paper discusses the construction of a smart file system. The three design examples show the system has the salient features of search and logic operations, and the advantages and difficulties of the system are foreseen. The system will facilitate the factories in the pharmaceutical 4.0 background to efficiently and conveniently utilize all kinds of documents for information retrieval and logic operations, which will make the research and development and registration of medicines more scientific, systematic and orderly, and also facilitate the international standardization of input and establishment of green Low-carbon, information technology, intelligent, international pharmaceutical core technology platform.